BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER BIHEX Ø3 W/T-HANDLE

    MDR report key: 3239197 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04366
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE INVESTIGATION OF THE ALLEGED SCREWDRIVER HAS SHOWN THAT THE TIPS ARE COMPLETELY BROKEN. UNFORTUNATELY WE ARE NOT ABLE TO COMPREHEND EXACTLY AFTERWARDS THE EXACT REASON FOR THE PROBLEM THAT OCCURRED. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF HIGH MECHANICAL OVERLOAD DURING APPLICATION WAS LEADING TO THE DAMAGE. THE REVIEW OF MATERIALS AND MANUFACTURING DOCUMENTS REVEALED NO DEVIATION FROM THE SPECIFICATIONS. THE FRACTURE SURFACES ARE HOMOGENEOUS, WHICH ALSO INCLUDES AN IMPECCABLE MATERIAL QUALITY. CORRECTION: THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE TIP OF THE SCREWDRIVER IS BROKEN. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339432 SCREWDRIVER BIHEX Ø3 W/T-HANDLE HXX SYNTHES GMBH 3287279

    Patients

    Seq Age Sex Outcome Treatment
    1